Table 2.

Numbers of reports and RORs of cardiac adverse events related to pembrolizumab

Variable	Pembrolizumab		Other drugs		Rate (%)	ROR	95% CI	P-value
	Cases (n)	Non-cases (n)	Cases (n)	Non-cases (n)
Myocarditis	67	15,239	1,568	2,005,033	0.44	5.62	4.40–7.18	< 0.001
Cardiac failure	50	15,256	11,593	1,995,008	0.33	0.56	0.43–0.74	< 0.001
Immune-mediated myocarditis	41	15,265	108	2,006,493	0.27	49.90	34.82–71.52	< 0.001
Pericardial effusion	38	15,268	1,136	2,005,465	0.25	4.39	3.18–6.07	< 0.001
Cardiac tamponade	25	15,281	596	2,006,005	0.16	5.51	3.69–8.22	< 0.001
Atrial fibrillation	25	15,281	3,195	2,003,406	0.16	1.03	0.70–1.52	0.839
Cardiac arrest	17	15,289	3,451	2,003,150	0.11	0.65	0.40–1.04	0.077
Myocardial infarction	14	15,292	2,790	2,003,811	0.09	0.66	0.39–1.11	0.126
Hypertension	12	15,294	5,280	2,001,321	0.08	0.30	0.17–0.52	< 0.001
Pericarditis	12	15,294	747	2,005,854	0.08	2.11	1.19–3.73	0.018
Cardio-respiratory arrest	11	15,295	3,491	2,003,110	0.07	0.41	0.23–0.75	0.001
Cardiomyopathy	10	15,296	1,378	2,005,223	0.07	0.95	0.51–1.77	1.000
Arrhythmia	10	15,296	2,539	2,004,062	0.07	0.52	0.28–0.96	0.029
Acute myocardial infarction	9	15,297	2,251	2,004,350	0.06	0.52	0.27–1.01	0.051
Stress cardiomyopathy	9	15,297	849	2,005,752	0.06	1.39	0.72–2.68	0.318
Ventricular tachycardia	8	15,298	2,242	2,004,359	0.05	0.47	0.23–0.94	0.027
Cardiac failure congestive	8	15,298	2,898	2,003,703	0.05	0.36	0.18–0.72	0.001
Blood pressure decreased	8	15,298	12,746	1,993,855	0.05	0.082	0.04–0.16	< 0.001
Cardiac failure acute	7	15,299	2,138	2,004,463	0.05	0.43	0.20–0.90	0.017
Hypotension	7	15,299	4,233	2,002,368	0.05	0.22	0.10–0.45	< 0.001
Pericarditis malignant	6	15,300	20	2,006,581	0.04	39.34	15.80–97.99	< 0.001
Angina pectoris	5	15,301	2,059	2,004,542	0.03	0.32	0.13–0.77	0.003

“Cases” indicates the number of reported cases of cardiac adverse events. ROR: reporting odds ratio; 95%CI: 95% confidence interval. Italicized P-values represent statistically significant results. We obtained data for each type of cardiac adverse event showing more than five reports. All analysed data were obtained from the Japanese Adverse Drug Event Report database